Anika
Therapeutics, Inc. (Nasdaq: ANIK), a leader in products for tissue
protection, healing and repair, based on hyaluronic acid (HA)
technology, today announced that it has filed regulatory submissions in
both the United States and Europe seeking the approval of Cingal, the
Company’s novel HA plus steroid single-injection treatment for
osteoarthritis of the knee. Anika submitted its application for CE Mark
approval to commercialize Cingal in the European Union and also filed
its premarket approval application (PMA) with the U.S. Food and Drug
Administration to allow for marketing and distribution in the United
States.
“After meeting all of the primary and secondary endpoints from our
multinational Phase III Cingal clinical trial in a clinically and
statistically meaningful fashion, we filed the CE Mark application as
planned at the end of 2014 and submitted the PMA a few days ago, ahead
of schedule,” said Anika President and CEO Dr. Charles H. Sherwood. “The
filing of these submissions is a milestone achievement for Anika and,
after approvals, positions us extremely well in the market from a
competitive standpoint. In addition to the United States and Europe, we
plan to commercialize Cingal in other key markets in the world. We look
forward to patients benefiting from Cingal, which provides the
convenience and efficacy of our current single-injection treatment,
Monovisc®, with the added early symptom relief benefits of a
commonly used steroid.”
The Cingal Phase III trial was a 26-week, randomized, double-blind,
three-arm, placebo-controlled study designed to evaluate the efficacy
and safety of a single injection of Cingal in approximately 368 patients
experiencing joint pain from osteoarthritis of the knee who had not
responded to conservative treatment. Patients were randomized to receive
a Cingal treatment, a placebo treatment or a treatment of Anika’s
Monovisc product. After the initial treatment, patients were assessed
for 26 weeks at clinical sites in Europe and Canada. The primary
clinical effectiveness endpoint data measured the change in the
patients’ knee pain over the course of the trial from their baseline
level according to the WOMAC Pain Score.
About Anika Therapeutics, Inc.
Headquartered in Bedford, Mass., Anika
Therapeutics, Inc. develops, manufactures and commercializes
therapeutic products for tissue protection, healing and repair. These
products are based on hyaluronic
acid (HA), a naturally occurring, biocompatible polymer found
throughout the body. Anika's products range from orthopedic/joint health
solutions led by Orthovisc®
and Monovisc®,
treatments for osteoarthritis of the knee; to surgical aids in the anti-adhesion
and ophthalmic
fields. The Company also offers aesthetic
dermal fillers for the correction of facial wrinkles. Anika's
Italian subsidiary, Anika Therapeutics S.r.l., provides complementary HA
products in orthopedic/joint health and anti-adhesion, as well as
therapeutics in areas such as advanced wound treatment and ear, nose and
throat care. Its regenerative technology advances Anika's vision to
offer therapeutic products and medical solutions that go beyond pain
relief to protect and restore damaged tissue.
The statements made in this press release, which are not statements
of historical fact, are forward-looking statements within the meaning of
Section 27A of the Securities Act of 1933, as amended, and Section 21E
of the Securities Exchange Act of 1934, as amended. These statements
include, but are not limited to, those relating to the results of our
Cingal clinical trials, regulatory filings, and our expectations for
regulatory approvals and Cingal’s global commercialization strategy.
These statements are based upon the current beliefs and expectations of
the Company's management and are subject to significant risks,
uncertainties and other factors. The Company's actual results
could differ materially from any anticipated future results, performance
or achievements described in the forward-looking statements as a result
of a number of factors including (i) the Company's ability to
successfully commence and/or complete clinical trials of its products on
a timely basis or at all, obtain pre-clinical or clinical data to
support domestic and international pre-market approval applications or
510(k) applications, or timely file and receive FDA or other regulatory
approvals or clearances of its products, or that such approvals will not
be obtained in a timely manner or without the need for additional
clinical trials, other testing or regulatory submissions, as applicable;
(ii) the Company's research and product development efforts and their
relative success, including whether the Company has any meaningful sales
of any new products resulting from such efforts; (iii) the cost
effectiveness and efficiency of our clinical studies, including the
associated regulatory approval applications, our manufacturing
operations and our production planning; (iv) the strength of the
economies in which the Company operates or will be operating, as well as
the political stability of any of those geographic areas; (v) future
determinations by the Company to allocate resources to products and in
directions not presently contemplated; (vi) the Company’s ability to
successfully complete its commercialization plans for its products in
the U.S. and internationally; (vii) the Company’s ability to provide an
adequate and timely supply of its products to its customers; (viii) our
ability to continue to successfully manage Anika Therapeutics S.r.l.’s
business; and (ix) the Company’s ability to achieve its growth targets.
Certain other factors that might cause the Company's actual results to
differ materially from those in the forward-looking statements include
those set forth under the headings "Business," "Risk Factors" and
"Management's Discussion and Analysis of Financial Condition and Results
of Operations" in the Company's Annual Report on Form 10-K for the year
ended December 31, 2013, as well as those described in the Company's
other press releases and SEC filings.
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